Food-Effect and Metabolism Study in Healthy Subjects

Phase 1

Completed

• Conditions: Solid Tumor
• Interventions: Drug: Fluzoparib

• Registration Number: NCT03062982
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

This study evaluates the food-effect of one-dose Fluzoparib in healthy subjects. The participants receive Fluzoparib 120mg in fed state in Period 1 followed by administration of Fluzoparib 120mg in fasted state in Period 2.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-21
• Primary Completion: 2017-01-04
• Study Completion: 2017-01-04
• Status Verified: 2017-02
• Study First Submitted: 2017-02-09
• Study First Submitted QC: 2017-02-20
• Last Update Submitted: 2017-02-20
• Study First Posted: 2017-02-24
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Able and willing to give written informed consent.
• Must be willing to comply with the requirements of the study.
• Willing to use a medically acceptable method (as defined by the Investigator) of birth control in the 6 months.
• Male or female aged 18-50 years.
• Weight more than 45kg, BMI within 18 and 28 kg/m2.
• No clinically significant abnormalities in physical examination and lab tests.

Exclusion Criteria

• Pregnant or breast-feeding women.
• No history of alcohol or drug abuse within the past year.
• Participation in any clinical trial of an experimental drug or device in the previous 3 months.
• Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the subject unsuitable for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	Fluzoparib	Administration of 120mg in fed state in Dosing Period 1 followed by administration of 120mg in fasted state in Dosing Period 2
Group B	Fluzoparib	Administration of 120mg in fasted state in Dosing Period 1 followed by administration of 120mg in fed state in Dosing Period 2

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics - Cmax	pre-dose and then 0.25、0.5、1、1.5、2、3、4、6、8、10、12、24、36、48、72、96h	This study was designed to estimate the relative bioavailability of Fluzoparib 120 mg in the fed state relative to the fasted state.Peak Plasma Concentration (Cmax) and the the 90% confidence interval were calculated.
Pharmacokinetics-AUC	pre-dose and then 0.25、0.5、1、1.5、2、3、4、6、8、10、12、24、36、48、72、96h	This study was designed to estimate the relative bioavailability of Fluzoparib 120 mg in the fed state relative to the fasted state.Area under the plasma concentration versus time curve (AUC0-last，AUC0-infinity) and the 90% confidence intervals were calculated.
Pharmacokinetics - Tmax (Hours)	pre-dose and then 0.25、0.5、1、1.5、2、3、4、6、8、10、12、24、36、48、72、96h	To estimate the the time to Maximum concentration and constructe the corresponding 90% confidence intervals.
Collection of Feces and Urine and Measurement of 120mg Fluzoparib Metabolism in Healthy subjects by HPLC	0-96h post dose if availabel	This study was also designed to clarify the metabolism of Fluzoparib 120mg.

Trial Locations

Locations (1)

the First Hosital of Jilin University; 🇨🇳 Changchun, Jilin, China